Job Description Job Description Salary: Summary of Position: The R&D Engineer for Vein360 is an essential team member who supports the design and development of processes related to the restoration of previously used healthcare products to like-newcondition. The role relies heavily on reverse engineering, process validation, equipmentqualificationand the ability to define requirements for a broad variety of medical technologies by their intended use andprincipleof operation. Essential Functions: * Designsprocesses for the safe reprocessing of medical devices. * Utilizesengineering skill sets todevelopmentand implement standard test methods. * Generates test documentation whichcomprisethe design history file. * Coordinates and executes test and validation trials. * Complies withapplicable regulations (e.g., 21 CFR Part 820). * Gathers andmaintainsaccurateandtimelyrecords associated with tests and validations. * Works under a project plan, achieving milestones on time. * Reviews, analyzes, and documents test data for both in-house and contract laboratories. * Effectivelyleveragessoftware for word processing, data analysis, presentations, etc. * Assistsin theselectionof new equipment andqualificationof equipment. * Remains up to date and informed on relevant standards and regulations. * Participates in team decision making and routine meetings. * Prepares relevant documentation for design reviews and team meetings. * Creates and manages engineering change orders. * Supports a safe, healthy, and inclusive work environment. * Performs other duties as assigned. MinimumRequirements: Education: Bachelors degree in Mechanical / Biomedical Engineering, or related engineering field Experience: 5-15 years of medical device experience or closely related field Preferred Skills/Qualifications: Working knowledge of CAD software such as SolidWorks or Creo Skills/Competencies: * Ability tooperatelight machine tools, gages, and laboratory instruments * Proficient in MS Office with preferred knowledge of Visio and Project * Must be organized and effective at record maintenance * Understanding of Design of Experiments and statistical concept * Capable of writing and following advanced technical procedures Other Skills: Ready toidentify, analyze and implement improvements independently and to propose changes to existing methods, procedures,processesand/or products Working Conditions: Office environment with frequent sitting, walking, standing, kneeling, and occasional climbing.Lab environment, including proper use ofappropriate PPEfor handling used medical devices. Includes donning of smocks, foot covers, safety goggles, face shield, hairnetand latex free gloves for extended periods of time.Frequent use of hand-eye coordination while using equipment and tools.Visual capacity including depth perception, color vision, and peripheral vision enabling operation of office machinery, laboratoryequipmentand tools.Light physical effortrequiredby handling objects up to 30 pounds occasionally and up to 15 poundsfrequently. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification.They are not intended to be construed as an exhaustive list of all responsibilities, duties and skillsrequired ofemployees assigned to this position.
R&D Engineer • Cincinnati, OH, United States
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